BioDuro, a globally trusted Contract Research, Development, and Manufacturing Organization (CRDMO), has announced a strategic joint venture with Cenra API Solutions—also known as Chunghwa Chemical Synthesis & Biotech Co —to expand commercial-scale active pharmaceutical ingredient (API) production at Cenra’s Taipei campus.

 

The partnership merges BioDuro’s early-stage drug development expertise with Cenra’s decades-long track record in commercial GMP API manufacturing, creating an end-to-end solution for clients from discovery through commercial production.

 

The Taipei facility boasts 10 GMP API production lines, with a total reactor volume exceeding 350,000 liters, capable of producing up to 200 metric tons of API annually. It has passed inspections by major international regulators, including the U.S. FDA, EMA, Japan’s PMDA, and Taiwan’s TFDA.

 

“By combining BioDuro's integrated CMC expertise with Cenra's nearly six decades of GMP manufacturing excellence and enviable international regulatory history, our joint venture strengthens both companies' global supply chain resilience and minimizes the risks of technology-transfers,” said Armin Spura, CEO of BioDuro. 

 

“This collaboration allows us to provide customers with truly integrated services and a drug substance solution that spans discovery chemistry, process R&D, regulatory starting materials, advanced intermediates, and clinical- to commercial-scale API production, both inside and outside mainland China, accelerating the advance of innovative therapies to market, for patients worldwide.”

 

“BioDuro serves more than 1,500 global customers annually with industry-leading R&D and manufacturing capabilities,” added Wayne Hsiao, President of Cenra API Solutions. “We are excited to join forces to deliver highly integrated solutions and greater value to customers around the world.”